kombiglyze xr Drug Patent Profile
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When do Kombiglyze Xr patents expire, and what generic alternatives are available?
Kombiglyze Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-seven patent family members in thirty-two countries.
The generic ingredient in KOMBIGLYZE XR is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Kombiglyze Xr
A generic version of kombiglyze xr was approved as metformin hydrochloride; saxagliptin hydrochloride by DR REDDYS LABS SA on August 9th, 2023.
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Summary for kombiglyze xr
International Patents: | 57 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Clinical Trials: | 3 |
Patent Applications: | 54 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for kombiglyze xr |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for kombiglyze xr |
DailyMed Link: | kombiglyze xr at DailyMed |
Recent Clinical Trials for kombiglyze xr
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Basrah | N/A |
Karolinska Institutet | Phase 3 |
The First Affiliated Hospital of Guangzhou Medical University | Phase 3 |
Pharmacology for kombiglyze xr
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Paragraph IV (Patent) Challenges for KOMBIGLYZE XR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
KOMBIGLYZE XR | Extended-release Tablets | metformin hydrochloride; saxagliptin hydrochloride | 5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg | 200678 | 3 | 2013-07-31 |
US Patents and Regulatory Information for kombiglyze xr
kombiglyze xr is protected by two US patents.
Patents protecting kombiglyze xr
Coated tablet formulation and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Coated tablet formulation and method
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-003 | Nov 5, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-002 | Nov 5, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-003 | Nov 5, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-002 | Nov 5, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-001 | Nov 5, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for kombiglyze xr
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-002 | Nov 5, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-003 | Nov 5, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-001 | Nov 5, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-002 | Nov 5, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-003 | Nov 5, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for kombiglyze xr
See the table below for patents covering kombiglyze xr around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20120064141 | COATED TABLET FORMULATION AND METHOD | ⤷ Sign Up |
Colombia | 5280198 | INHIBIDORES A BASE DE PIRROLIDINA FUSIONADA CON CICLOPROPILO DE DIPEPTIDIL PEPTIDASA IV Y METODO | ⤷ Sign Up |
Mexico | PA06013711 | FORMULACION DE TABLETA REVESTIDA Y METODO. (COATED TABLET FORMULATION AND METHOD.) | ⤷ Sign Up |
Denmark | 1753406 | ⤷ Sign Up | |
Cyprus | 1117813 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for kombiglyze xr
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1506211 | PA2014026 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
2498758 | 2090013-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113 |
1506211 | 122014000070 | Germany | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
2498758 | 2020C/509 | Belgium | ⤷ Sign Up | PRODUCT NAME: QTRILMET - METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113 |
2498758 | PA2020003,C2498758 | Lithuania | ⤷ Sign Up | PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |